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510(k) Data Aggregation
K Number
K023712Device Name
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
Manufacturer
Date Cleared
2003-01-31
(88 days)
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advantage Multiple Drugs of Abuse Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of one to five of the following Drugs of Abuse at the indicated cut off: THC 50ng/mL, Phencyclidine (PCP) 25ng/mL, Opiates 2000 ng/mL, Cocaine 300ng/mL, Amphetamine 1,000ng/mL and Methamphetamine 1,000ng/mL. The tests are formatted in multiple plastic test cards, which hold up to 5 drug test strips, and single plastic test cards which hold one drug test strip. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. The test is for professional use.
Device Description
The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test. The tests are formatted in a multiple plastic card, which holds up to 5 drug test strips, and a single plastic test card, which holds a single drug test strip.
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K Number
K013778Device Name
PEACE OF MIND HOME DRUG TEST
Manufacturer
Date Cleared
2002-02-07
(86 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|-----------------|-----------|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|-----------------|-----------|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
Device Description
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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K Number
K011962Device Name
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
Manufacturer
Date Cleared
2001-08-09
(48 days)
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advantage Marijuana (THC) and Cocaine Home Drug Test is designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL and Cocaine metabolites at a cut off of 300ng/mL.
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of THC and /or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
Device Description
The Advantage Marijuana (THC) and Cocaine Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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K Number
K010921Device Name
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
Manufacturer
Date Cleared
2001-06-25
(90 days)
Product Code
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003708Device Name
ADVANTAGE THC/COCAINE TEST
Manufacturer
Date Cleared
2001-01-22
(52 days)
Product Code
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001567Device Name
ADVANTAGE THC TEST
Manufacturer
Date Cleared
2000-06-19
(31 days)
Product Code
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K994227Device Name
ADVANTAGE HCG TEST (URINE/SERUM)
Manufacturer
Date Cleared
2000-02-03
(50 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advantage hCG Test (Urine/Serum) is a qualitative, rapid immunochromatographic assay used to detect the presence of hCG in human urine and serum for the early detection of pregnancy. The test is intended for use in clinical laboratories by health care professionals.
Device Description
The Advantage hCG Test (Urine/Serum) is an immunochromatographic based one step in vitro test.
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K Number
K991883Device Name
REDI-TEST OPIATES
Manufacturer
Date Cleared
1999-09-15
(105 days)
Product Code
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE DIAGNOSTICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
Device Description
The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
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